Adaptimmune Receives Access to Priority Medicines (PRIME) Regulatory Support for its SPEAR® T-cell Therapy Targeting NY-ESO for Treatment of Soft Tissue Sarcoma
New Initiative Provides Access to Scientific Advice and Supports Accelerated Assessment for Therapies Targeting Unmet Medical Needs
PHILADELPHIA, Pa. and OXFORD, UK, July 28, 2016 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, today announced that the European Medicines Agency (EMA) has granted access to its newly-established Priority Medicines (PRIME) regulatory initiative for the company’s SPEAR® T-cell therapy targeting NY-ESO for the treatment of HLA-A0201, HLA-A0205, or HLA-A0206 allele positive patients with inoperable or metastatic synovial sarcoma who have received prior chemotherapy and whose tumor expresses the NY-ESO-1 tumor antigen.
The PRIME initiative provides support to optimize regulatory applications and accelerate the review of medicines that address a high unmet need.
“Access to the PRIME initiative represents an important regulatory opportunity for us. It can provide early engagement on the development program with potential for accelerated assessment of data to companies like Adaptimmune who are developing new treatment modalities for patients in Europe with few or no treatment options,” said Rafael Amado, Adaptimmune’s Chief Medical Officer. “Our NY-ESO SPEAR T-cell therapy may help to address the significant unmet medical need of metastatic or unresectable synovial sarcoma. We look forward to working closely with the EMA throughout its clinical evaluation.”
Adaptimmune recently announced that the European Commission had designated its NY-ESO SPEAR T-cell therapy as an orphan medicinal product for the treatment of soft tissue sarcoma. The company has already received orphan drug designation and Breakthrough Therapy designation for its NY-ESO SPEAR T-cell therapy from the U.S. Food and Drug Administration.
The PRIME initiative focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. The criteria for the PRIME initiative require a medicine to show its potential to benefit patients with unmet medical needs based on early clinical data. The initiative offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applications, and provides appointment of a rapporteur, early dialogue on the overall development plan and regulatory strategy, scientific advice at key development milestones, a dedicated point of contact, and the potential to qualify products for accelerated assessment at the time of an application for marketing authorization.
Adaptimmune’s SPEAR T-cell candidates are novel cancer immunotherapies that have been engineered to target and destroy cancer cells by strengthening a patient’s natural T-cell response. T-cells are a type of white blood cell that play a central role in a person’s immune response. Adaptimmune’s goal is to harness the power of the T-cell and, through its multiple therapeutic candidate, significantly impact cancer treatment and clinical outcomes of patients with solid and hematologic cancers.
Adaptimmune is a clinical stage biopharmaceutical company focused on novel cancer immunotherapy products based on its SPEAR® (Specific Peptide Enhanced Affinity Receptor) T-cell platform. Established in 2008, the company aims to utilize the body’s own machinery - the T-cell - to target and destroy cancer cells by using engineered, increased affinity TCRs as a means of strengthening natural patient T-cell responses. Adaptimmune’s lead program is a SPEAR T-cell therapy targeting the NY-ESO cancer antigen. Its NY-ESO SPEAR T-cell therapy has demonstrated signs of efficacy and tolerability in Phase 1/2 trials in solid tumors and in hematologic cancer types, including synovial sarcoma and multiple myeloma. Adaptimmune has a strategic collaboration and licensing agreement with GlaxoSmithKline for the development and commercialization of the NY-ESO TCR program. In addition, Adaptimmune has a number of proprietary programs. These include SPEAR T-cell therapies targeting the MAGE-A10 and AFP cancer antigens, which both have open INDs, and a further SPEAR T-cell therapy targeting the MAGE-A4 cancer antigen that is in pre-clinical phase with IND acceptance targeted for 2017.The company has identified over 30 intracellular target peptides preferentially expressed in cancer cells and is currently progressing 12 through unpartnered research programs. Adaptimmune has over 250 employees and is located in Oxfordshire, U.K. and Philadelphia, USA. For more information: http://www.adaptimmune.com
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 12, 2016, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.
Adaptimmune Contacts Will Roberts Vice President, Investor Relations T: (215) 825-9306 E: firstname.lastname@example.org Margaret Henry Head of PR T: +44 (0)1235 430036 Mobile: +44 (0)7710 304249 E: email@example.com
Released July 28, 2016